CN114340698A

CN114340698A - Palm activated drug delivery device

Info

Publication number: CN114340698A
Application number: CN202080060463.0A
Authority: CN
Inventors: R·赫兹基亚胡
Original assignee: West Pharmaceutical Services Inc
Current assignee: West Pharmaceutical Services Inc
Priority date: 2019-08-12
Filing date: 2020-07-30
Publication date: 2022-04-12
Also published as: EP4013473A1; WO2021030066A1; JP2022544283A; US20220305213A1; JP7389226B2

Abstract

A drug administration device is provided that includes an upper housing and a lower housing. The lower housing supports a syringe having a needle. The needle guard is in sliding engagement with the lower housing and is movable proximally from a first position, in which the needle guard conceals the tip of the needle, to a second position, in which the needle guard exposes the tip of the needle. The upper housing is configured to receive a distally directed force and move relative to the lower housing from a pre-use position to a dispensing position in response to a manual force. When the upper housing is in the pre-use position and the needle guard is in the first position, the upper housing cannot be moved toward the dispensing position. Proximal movement of the needle guard from the first position to the second position releases the upper housing to move to the dispensing position in response to the force.

Description

Palm activated drug delivery device

Cross Reference to Related Applications

This application claims priority from U.S. provisional patent application No. 62/885,434 entitled "Palm Activated Drug Delivery Device," filed on 12.8.2019, the entire contents of which are incorporated herein by reference.

Background

Embodiments described herein relate generally to methods and devices for parenteral drug delivery. The device provides assisted manual drug delivery and confirms completion of the drug delivery process. The device provides a system with improved safety and ease of use and provides audible or other forms of feedback to the user to indicate when drug delivery is proceeding, completed, or both to avoid one or both of incomplete dosing and drug waste, and a system with improved safety and ease of use.

Many patients have a fear of needles. In situations where self-administration is required, such as those requiring multiple, daily injections, patients may not be able to administer their medication according to their prescribed regimen due to fear of needles, pain often associated with injections, dexterity required to properly administer medication via needles and syringes, or other similar factors. For some persons with impaired vision, dexterity or perception, self-administration via needles and syringes may present additional difficulties which may prevent them from receiving the medication they desire.

In addition to the social stimulation associated with needle and syringe medication regimens, there are safety and disposal issues associated with needles and syringes, which may be caused by contaminated needles, accidental sticks, cross-contamination, etc., not only for patients, but also for those around them. Despite these disadvantages, however, many patients are encouraged to use needles and syringes to deliver their medication because the speed of needle insertion and drug delivery can be controlled, and therefore the perception of pain and discomfort associated with this type of medication injection can be controlled.

Accordingly, there are many opportunities for development in the field of episodic, parenteral drug delivery that can overcome "needle phobia", reduce pain in patients, and increase the safety, reliability, and efficacy of many drug treatment regimens.

Disclosure of Invention

Briefly, one aspect of the present disclosure is directed to a device configured to administer a medicament. The device includes a lower housing configured to support a medication holding syringe having a needle. The lower housing includes a housing latch having a leg extending proximally from a portion of the lower housing to a free tip and a protrusion extending radially from the leg. The legs are laterally resiliently flexible relative to an axial central axis of the device. The needle guard is supported by and in sliding engagement with the lower housing and is movable in a proximal direction relative to the lower housing from a first position in which the distal end of the needle guard is configured to conceal the distal tip of the needle to a second position in which the distal end of the needle guard is configured to expose the distal tip of the needle. The needle guard has an elongated extension with an opening that receives a radially extending protrusion of the housing latch therethrough. The needle guard also has a protrusion extending laterally into the opening, the laterally extending protrusion having a cam extending radially inward therefrom. The upper housing has an abutment surface and is supported relative to the lower housing and is configured to receive a distally directed manual force and move in a distal direction relative to the lower housing from a pre-use position to a dispensing position in response to the manual force. When the upper housing is in the pre-use position and the needle guard is in the first position, the radially extending projection of the housing latch releasably interferes with the abutment surface of the upper housing, thereby preventing the upper housing from moving relative to the lower housing toward the dispensing position. Proximal movement of the needle guard from the first position to the second position moves the cam of the needle guard into abutment with the leg of the housing latch. The cam causes the legs to resiliently flex laterally to move the radially extending projection of the housing latch out of interference with the abutment surface of the upper housing to release the upper housing to move from the pre-use position to the dispensing position in response to manual force.

Drawings

The foregoing summary, as well as the following detailed description of various aspects of the present disclosure, will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the present disclosure is not limited to the precise arrangements and instrumentalities shown, and reference is made to the claims herein for that purpose. In the drawings:

fig. 1A is a side elevation view of an embodiment.

Fig. 1B is a side view of the embodiment of fig. 1A after removal of the cover.

Fig. 1C is a side view of the embodiment of fig. 1B after the interlock button has been depressed.

Fig. 1D is a side view of the embodiment of fig. 1C after retraction of the needle guard, thereby exposing the needle.

Fig. 2A is a side view of the embodiment of fig. 1D during injection of a drug.

Fig. 2B is a side view of the embodiment of fig. 2A upon completion of the injection of the drug.

Fig. 2C is a side view of the embodiment of fig. 2B after the needle guard has been extended, thereby concealing the needle.

Fig. 3 is a depiction of an exploded view of the embodiment of fig. 1A.

Fig. 4 is a depiction of a cross-sectional view of the embodiment of fig. 1A.

Fig. 5 is a depiction of a partial cross-sectional view of a portion of the embodiment of fig. 1A depicting a latch.

Fig. 6 is a depiction of a partial cross-sectional view of a portion of the embodiment of fig. 1A depicting a latch.

Fig. 7 is a depiction of a cross-sectional view of the embodiment of fig. 2A.

Fig. 8 is a depiction of a cross-sectional view of the embodiment of fig. 2B.

FIG. 9 is a depiction of a cross-sectional view of the embodiment of FIG. 2C

Fig. 10A is a side view of another embodiment.

Fig. 10B is a side view of the embodiment of fig. 10A after removal of the cover.

Fig. 10C is a side view of the embodiment of fig. 10B after retraction of the needle guard, thereby exposing the needle.

Fig. 11A is a side view of the embodiment of fig. 10C during injection of a drug.

Fig. 11B is a side view of the embodiment of fig. 11A upon completion of the injection of the medicament.

Fig. 11C is a side view of the embodiment of fig. 11B after the needle guard has been extended, thereby concealing the needle.

Fig. 12 is a depiction of an exploded view of the embodiment of fig. 10A.

Fig. 13A is a perspective view of the lower housing of the embodiment of fig. 10A.

Fig. 13B is a perspective view of the intermediate housing of the embodiment of fig. 10A.

Fig. 14 is a depiction of a partial cross-sectional view of a portion of the upper and middle housings of the embodiment of fig. 10A.

FIG. 15 is a depiction of the latch mechanism of the embodiment of FIG. 10A

Fig. 16 is a depiction of another latch mechanism of the embodiment of fig. 10A.

Fig. 17A is a depiction of a cross-sectional view of a portion of the embodiment of fig. 10A.

Fig. 17B is a depiction of a perspective view of a portion of the lower housing of the embodiment of fig. 10A.

Fig. 18 is a cross-sectional view of the device of fig. 10A.

Fig. 19 is an exploded side view of another embodiment.

Fig. 20 is a depiction of a cross-sectional side view of another embodiment prior to use.

Fig. 21A is a perspective view of an alternative design of the lower housing of the embodiment of fig. 10A.

Fig. 21B is a perspective view of an alternative embodiment of the lower housing of fig. 10A.

Fig. 21C is a cross-sectional view of the lower housing of fig. 21B.

Fig. 22A is a front perspective view of another embodiment of a drug delivery device in a pre-use position.

Fig. 22B is a front elevational view of the drug delivery device shown in fig. 22A in a post-use position, with the upper housing substantially covering the middle housing.

Fig. 22C is a cross-sectional view of the drug delivery device shown in fig. 22A.

Fig. 22D is a cross-sectional view of the drug delivery device shown in fig. 22B with the needle guard in the second position whereby the needle is exposed.

Fig. 22E is a cross-sectional view of the drug delivery device shown in fig. 22D with the needle guard in a final position whereby the needle is encapsulated.

Fig. 23 is an exploded view of the drug delivery device shown in fig. 22A.

Fig. 24A is a bottom perspective view of the upper housing body shown in fig. 23.

Fig. 24B is a side elevational view of the upper housing illustrated in fig. 24A.

Fig. 24C is a cross-sectional view of the skirt shown in fig. 23.

Fig. 25A is a perspective view of the intermediate housing shown in fig. 23.

Fig. 25B is an enhanced side elevational view of the intermediate housing shown in fig. 25A.

Fig. 25C is a cross-sectional view of the drug delivery device shown in fig. 22A.

Fig. 26A is a perspective view of the lower housing shown in fig. 23.

Fig. 26B is a front perspective view of the lower housing shown in fig. 26A.

Fig. 27A is a perspective view of the syringe retainer shown in fig. 23.

Fig. 27B is a perspective view showing a syringe being inserted into the syringe holder of fig. 27A.

Fig. 27C is a perspective view of the syringe and syringe retainer combination of fig. 27B being inserted into the lower housing.

Fig. 28A is a perspective view of the needle guard shown in fig. 23.

Fig. 28B is an enlarged partial perspective view of the needle guard of fig. 28A.

Fig. 28C is a partial perspective view of the drug delivery device shown in fig. 22A with the intermediate housing removed.

Fig. 28D is a top plan sectional view of the drug delivery device shown in fig. 22A.

Fig. 29A is a partial front elevational view of the drug delivery device shown in fig. 22A when the upper housing is in the pre-use position and the needle guard is in the first position.

Fig. 29B is a partial front elevational view of the drug delivery device shown in fig. 29A with the upper housing guide removed for clarity.

Fig. 29C is a partial front elevational view of the drug delivery device shown in fig. 29B with the upper housing moved toward the dispensing position.

Fig. 29D is a partial front elevational view of the drug delivery device shown in fig. 29C with the upper housing in a dispensing position.

Fig. 29E is a partial front elevational view of the drug delivery device shown in fig. 29D with the upper housing guide removed when the upper housing is in the dispensing position and the needle guard begins to move from the second position and toward the final position for clarity.

Fig. 29F is a partial front elevational view of the drug delivery device shown in fig. 29E when the needle guard is locked in the final position.

Fig. 30A is a front elevational view of the drug delivery device shown in fig. 22A in a pre-use position.

Fig. 30B is a front elevational view of the drug delivery device shown in fig. 30A with the cap removed to expose the needle guard.

Fig. 30C is a front elevational view of the drug delivery device illustrated in fig. 30B with the needle guard in the second position.

Fig. 30D is a front elevational view of the drug delivery device shown in fig. 30C with the upper housing moved toward the dispensing position.

Fig. 30E is a front elevational view of the drug delivery device shown in fig. 30D with the upper housing in the dispensing position.

Fig. 30F is a front elevational view of the drug delivery device shown in fig. 30E with the needle guard in a final position.

Detailed Description

The following detailed description is read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings, which are not necessarily to scale, depict exemplary embodiments for the purpose of explanation only and are not intended to limit the scope of the present disclosure. The detailed description illustrates by way of example, not by way of limitation, the principles of the disclosure.

Certain terminology is used in the following description for convenience only and is not limiting. The words "lower," "bottom," "upper," and "top" designate directions in the drawings to which reference is made. According to the present disclosure, the words "inwardly", "outwardly", "upwardly" and "downwardly" refer to directions toward and away from, respectively, the geometric center of the drug delivery device and designated parts of the drug delivery device. Unless specifically set forth herein, the terms "a," an, "and" the "are not limited to one element, but are to be understood to mean" at least one. The terminology includes the words set forth above, derivatives thereof, and words of similar import.

It will also be understood that when referring to dimensions or characteristics of components of the present disclosure, the terms "about," "approximately," "substantially," and the like are used herein to indicate that the dimensions/characteristics are not strictly boundaries or parameters and do not exclude minor variations thereof that are functionally similar. At the very least, such references, including numerical parameters, will include variations that do not alter the least significant digit using art-recognized mathematical and industrial principles (e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.).

Embodiments described herein relate to drug delivery devices and methods of use thereof. Embodiments of the disclosed devices and methods include a device configured to be invisible to a user and inaccessible to the needle, thereby reducing the likelihood of needle phobia and needle contamination. This includes automatically shielding the needle after drug delivery.

Embodiments of the device have an ergonomic form factor that allows for one-handed operation and conveniently allows for injection of alternative sites, such as the legs, arms, or abdomen. In embodiments that include a pressure sensitive trigger, the needle guard latch inhibits movement of the needle. In this way, the device includes a safety mechanism that will not allow the needle to be exposed if the needle is not pressed against the injection site.

One embodiment of a device including a window 104 to view the drug prior to use is shown in fig. 1A-1D. After the device has been used, a colored indicator may appear in the window to provide a visual indication to the user whether the device's medication has been used up. Furthermore, increased safety and a reduced likelihood of accidental needle stick injuries are provided after the drug is delivered.

To ensure that the user knows the status of the drug delivery and whether the drug delivery is complete, this embodiment includes a pawl and ratchet, such as those shown by pawl 117 and ratchet 116 shown in fig. 4 and 7, that engage to produce one or more audible clicks when the injection is complete. Such a mechanism may signal to the user that the dose has been delivered and may remove the device from the skin, preventing premature withdrawal of the device from the injection site. Thus, the user is actively involved during the entire delivery process.

To provide greater feedback to the user, the disclosed pawl and ratchet system also provides an audible click and movement of the device during delivery to indicate that an injection is being performed. In another embodiment, a louder click, alone or in combination with a visual indicator, at the end of delivery provides feedback confirming that delivery is complete.

Furthermore, the embodiments described herein have a friendly, non-disintegrating design and method of operation, wherein the user controls needle insertion and injection of the drug as described below.

An exemplary apparatus is shown in fig. 1-9. Embodiments of the device at various stages up to the injection of the drug are shown in fig. 1A to 1D, and embodiments during and after the injection of the drug are shown in fig. 2A to 2C. Fig. 1A shows the device 100 in its pre-use configuration as it may be received by a user. In this relaxed position, the upper housing 101 partially covers a proximal or uppermost portion of the lower housing 102. In describing various embodiments of the device, the term "proximal" is used with respect to the upper end of the device and "distal" is used with respect to the bottom surface of the device. For example, in fig. 1B, the distal side is used relative to the bottom surface or bottom 131 of the device 100.

As shown, the outwardly visible features of the device include an upper housing 101, a lower housing 102, a cover 103, a window 104, an interlock button 105, a grip ring 106, a bottom edge 111 of the upper housing 101, and a dose indicator 107. Fig. 3 is an exploded view of the components of this embodiment.

A preliminary step in using the device is to remove the cover 103 removably attached to the lower housing 102, as shown in fig. 1B. The cap 103 is removed while the needle shield 113 is removed and the needle guard 108 is exposed. The window 104 and the needle guard slot 109 (each of which is preferably present on both sides of the device) allow a user to view and inspect the internally contained syringe 118 and its drug contents.

In use, the device 100 is grasped by placing a palm of the hand over the top of the upper housing 101, similar to how a person grasps a floor mounted automotive shift lever. Grip ring 106 provides a visual cue to the user how to grasp the device. In one embodiment, the grip ring 106 is covered, coated or otherwise made of a suitable elastomeric material, including but not limited to neoprene, urethane, polyurethane, silicone, natural rubber, thermoplastic elastomer ("TPE"), or combinations thereof, to provide a slip-resistant and comfortable gripping surface.

The user presses the device 100 against the body by downward pressure of the palm on the gripping ring 106 and the interlock button 105 at the desired injection site, typically the top or sides of the thighs, the abdomen or sides or back of the upper arms. Pressure of the palm on interlock button 105 deflects it downward, as shown in fig. 2A, which in turn unlocks needle guard latch 124, as shown in fig. 5, allowing needle guard 108 to slide upward and expose needle 110 (note that some device components have been removed from fig. 5 for purposes of illustration). The needle guard latch 124 is integrally formed with a portion of the distal end of the upper housing sleeve 120. The upper housing sleeve 120 is a hollow cylinder, a portion of which is located in the upper housing 101 and a portion of which is located in the lower housing 102 when the device is in the relaxed position. The upper housing sleeve 120 is fixedly attached to the upper housing 101 and performs a latching function and serves to capture the biasing element 119 against the lower housing 102, as described in more detail below.

Needle guard latch 124 includes an inward ramp 127 relative to the longitudinal central axis a-a' of the device and a stop 130 at its uppermost end. To unlock the needle guard latch 124, an outwardly ramped surface 128 forming a distal end of the interlock button extension 123 complementary to the surface 127 engages the ramped surface 127 on the needle guard latch 124. The engagement of

surfaces

127 and 128 deflects needle guard latch 124 outwardly relative to the central axis, removing stopper 130 from blocking upward movement of needle guard 108. The latch mechanism and needle guard 108 are preferably configured such that upward movement of the needle guard 108 is prevented unless the interlock button 105 is fully depressed. This protects the needle from contamination and damage due to contact with other surfaces, protects the user from accidental needle stick injuries, and prevents the needle from being seen.

As the user continues to press down on the upper housing 101, the needle guard 108 moves upward, exposing and allowing the needle 110 to penetrate the user's skin, stopping when the bottom surface 131 of the lower housing 102 lies substantially flat against the skin. Once the needle guard 108 clears the stopper 130, the user may release the interlock button 105, or choose not to release, without affecting the remaining injection steps. When the interlock button 105 is released, the elastic member 121 returns the interlock button 105 to the upward position. The moving guide 132 serves to ensure the interlocking button travels straight upward and downward.

The needle insertion process described herein provides insertion control to the user. This feature allows the user to take advantage of the usual methods typically employed by insulin-dependent diabetics: if the needle is brought into contact with the skin and held there without piercing the skin, the user will no longer feel the presence of the needle after a few seconds, at which point the needle can be inserted painlessly by increasing the pressure applied to the needle.

After the needle 110 has been inserted into the user's body, the injection process typically begins, as shown in fig. 2A-2C. Referring to fig. 6, a housing latch 122 that is part of the lower housing 102 is shown in close-up detail and prevents the upper housing 101 from moving relative to the lower housing 102 in the pre-use state of the device (note that some device components have been removed from fig. 6 for purposes of illustration). When the needle guard 108 has completed its upward travel, the ramped surface 133 on the needle guard 108 contacts the ramped portion of the surface 134 that forms the end of the housing latch 122, deflecting the housing latch 122 inward, allowing the upper housing 101 and the upper housing sleeve 120 to move downward.

After inserting the needle 110 into the body, the user maintains pressure on the upper housing 101. As shown in fig. 3, 4, 7 and 8, the plunger rod 115 pushes the plunger 112. Plunger rod 115 is fixedly connected to upper housing 101 and syringe 118 is fixed or retained in a cylinder formed within lower housing 102. Thus, as upper housing 101 moves downward relative to lower housing 102 and over the lower housing, medicament within syringe 110 is delivered to the patient through needle 110 by the downward movement of plunger rod 115 and plunger 112 within syringe 118.

After the housing latch 122 is disengaged, the biasing element 119 around the distal end of the upper housing sleeve 120 is released from tension to exert a downward force on the upper housing 101 by exerting a downward force on the upper housing sleeve 120 fixedly attached to the upper housing 101 uppermost. The biasing element 119 may also be used to provide energy to assist in the advancement of the plunger rod 115 and plunger 112, wherein the user provides the additional required force to cause injection of the medicament, or the energy provided by the biasing element 119 may only be sufficient to advance the plunger rod 15 and plunger 112. In another embodiment, the biasing element 119 provides sufficient force to inject the medicament without requiring the user to input additional force, thereby providing an injection device in which the needle is manually inserted and the medicament is automatically injected. The biasing element may be any component capable of exerting a downward force on the upper housing sleeve 120 to a desired degree and may be, but is not limited to, a spring, a compressed gas actuator, a hydraulic drive, a wax actuator, an electrochemical actuator, a shape memory alloy, and the like, and combinations thereof. In the embodiment depicted in fig. 1-9, the user provides the additional force required to advance the plunger rod 115 and plunger 112 by pressing down on the upper housing 101. Thus, similar to the way power steering in a car reduces the force required by the driver to turn the steering wheel, the force required by the user to inject the drug is reduced. The user provides the force required for injection and the device provides the user with control over the rate of injection of the medicament.

Referring to fig. 4 and 7, cross-sectional views of embodiments both before and after the start of delivery of the drug are shown, respectively. As the medicament is delivered, a pawl 117 attached to the upper housing sleeve 120 moves along a ratchet 116 attached to the lower housing 102. The pawl 117 and ratchet 116 can serve at least two functions. First, the upper and

lower housings

101 and 102 are prevented from being separated by pulling them apart. Second, the movement of the pawl 117 along the ratchet 116 produces a soft click, providing feedback to the user that the upper housing 101 is moving and that medication is being delivered. Additionally, and as shown in fig. 8, at the end of travel of the upper housing 101, the pawl 117 may be configured to engage a deeper groove in the ratchet 116, thereby creating a louder click, which may provide an audible signal to the user that the end of travel has been reached and the medicament has been fully delivered, and further lock the upper housing 101 in place to prevent resetting or reuse of the device.

Referring to fig. 2B and 8, when the medicament is fully injected and the upper housing 101 is at the end of its travel, the bottom edge 111 of the upper housing 101 covers the dose indicator 107. The dose indicator 107 is a circumferential colored ring located at a distal portion of the lower housing 102. This provides a visual cue to the user that drug delivery has been completed.

Prior to use, the patient may view the drug through the window 104 to check its transparency and particulates. After use, the plunger 112 may be viewed in the window 104, indicating that the device has been used. Alternatively, the window may be designed such that the plunger rod 115 is also visible after the injection is completed. The plunger 112 and plunger rod 115 may be brightly colored to provide a clear indication to the patient that the device has been used.

Referring to fig. 2C and 9, after the injection is completed, the user removes the device 100 from the skin and the needle guard return element 114 extends the needle guard 108 over the needle 110, thereby protecting the user and others from accidental needle sticks. The needle guard return may be any element capable of extending the needle guard 108 over the needle 110, including but not limited to springs, compressed gas actuators, hydraulic drivers, wax actuators, electrochemical actuators, shape memory alloys, and the like, and combinations thereof. Once needle guard 108 is fully extended, needle guard lock 125 engages a slot in needle guard 108, preventing needle guard 108 from retracting. The needle guard lock 125 is a cantilevered latch extending inwardly from the inner surface of the upper housing sleeve 120. Lower housing rib 126, a portion of lower housing 102, may be configured to prevent needle guard lock 125 from prematurely engaging a slot in needle guard 108 during delivery by blocking the slot. In another embodiment, if the device 100 is removed before delivery is complete, the needle guard 108 may be extended and locked into place to prevent reuse or sharing of the device.

With the assisted delivery method, the user is actively engaged throughout the delivery process. The secondary activation method reduces development time and costs associated with improving injection devices for delivering different drugs because the user controls the delivery rate by varying the force applied to the upper housing 101. If the plunger is slightly stuck, the user may apply a slightly greater force.

In another embodiment, interlock button 105 and interlock spring 121 may be omitted from the design. In this embodiment, the upper housing 101 is free to move downward before hitting the stop. This movement is used to unlock needle guard 108 using a mechanism similar to the interlock mechanism described above, allowing needle guard 108 to retract. Once the needle guard 108 is fully retracted, it can disengage the other latch, which allows the upper housing 101 to stop moving downward and inject the medicament in a manner similar to that described above.

Another embodiment is depicted in fig. 10-18. In fig. 10A, a device 200 is shown having an upper housing 205, a lower housing 202, and an intermediate housing 201 therebetween. The upper housing 205 includes a capture cover 228. In the relaxed position, the upper housing 205 partially covers a proximal portion of the middle housing 201. The distal-most portion of the middle housing 201 is fixedly seated in the lower housing 202. Also shown in fig. 10A are upper housing bottom edge 211, travel ridge 216, and window 204. The window 204 is preferably seated within a distal portion of the lower housing 202. On the opposite side from the window 204 there is preferably a second window on the device, not shown.

The cap 203 is removably attached to the lower housing 202 and, in fig. 10B, is shown removed from the device 200 to expose the needle shield 213, the needle shield clamp 217, and the needle guard 208. During removal of cap 203, needle shield clamp 217 grasps and simultaneously removes needle shield 213, exposing needle shield 208 to the user. When the device user presses the needle guard 208 against the skin, this action slides the needle guard 208 upward, exposing the needle 210, as shown in fig. 10C.

Fig. 12 is an exploded view of the device 200. The capture cover 228 includes a capture cover assembly pin 230 that securely secures the capture cover 228 to the upper housing 205. The assembly pins 230 mate with holes 242 in the upper housing 205. Preferably, the assembly pin 230 is square in cross-section, with rounded corners, providing an interference surface between the corners of the assembly pin 230 and the holes 242. The guide member 233 and plunger rod 215 are shown integral with and extending downwardly from the interior surface of the gripping cap 228. Plunger rod 215 includes a damper 221 at its distal end. A syringe 218 having a plunger 212 and a needle shield 213 is also shown.

In a preferred embodiment, the outer surface of the gripping cap 228 is coated with or formed from a material capable of providing a soft, non-slip grip for the user, or the entire gripping cap 228 is formed therefrom. Suitable materials for coating or forming the grip cap include, but are not limited to, elastomeric materials such as neoprene, urethane, polyurethane, silicone, natural rubber, TPE, and the like, and combinations thereof.

The upper housing 205 includes a snap latch 220, a handle rib guide 238, and a bottom edge 211. For the snap latch 220, as well as other latches used in the device, it is preferred that at least two latches are used, and the same latches are symmetrically positioned relative to each other to facilitate smooth movement and operation of the device.

The middle housing 201 is shown in fig. 12 as having a body 207 and a handle guide slot 239 on an outer surface of a proximal portion of the body 207. When the device is used, a handle rib guide 238, which is an integral part of the upper housing 205, engages and slides within a handle guide slot 239, thereby maintaining smooth and controlled movement of the upper housing 205 during drug delivery.

The body 207 may act as a dose indicator in that the upper housing 205 is lowered over the body 207 when the device is activated. When the full dose of medicament has been delivered, the body 207 is completely obscured by the upper housing 205, as shown in fig. 11C. Preferably, the body 207 is colored, more preferably brightly colored, or patterned to provide easy-to-observe visual feedback to the user that the administration is ongoing or completed. Optionally, a scale may be included on the body 207 to visually quantify the amount of drug that has been delivered or is to be delivered.

Referring to fig. 13B, intermediate housing 201 also includes a capture latch 224, a snap latch capture slot 236, and a needle guard latch 237. The capture latch 224 is a generally rectangular element that is movably attached at a distal-most portion to an inner surface 243 of the middle housing 201 such that it can move outwardly toward the inner surface 243 upon application of a force. The capture latch 224 also includes a stop surface 245 and a triangular stop 244 extending inwardly from a top-most one of its corners toward the center of the device. In the rest, pre-use position of the device, the catch latch 224 prevents the upper housing 205 from moving relative to the intermediate housing 201 as the stop 245 interferes with the downward travel of the guide 233 of the catch cap 228.

Referring to fig. 12-13B, lower housing 202 is shown having lower housing base 206, ends of travel ridges 216, window 204, housing latch 229, guide slot 227, and syringe retainer clip 235. The cover 203 is removably attached to the lower housing base 206 by a cover retaining ring 234. In use, the lower housing base 206 contacts the skin of the user and is therefore preferably made of any of the soft, flexible materials suitable for gripping the cover 228.

The window 204 provides an opening in the lower housing 202 for viewing the contents of the syringe 218. The window 204 is positioned so that the bottom of the syringe 218 is visible to the user, allowing the user to verify that the plunger 212 has reached the end of its travel to the bottom of the syringe. The window 204 may be of any convenient size and shape, and is preferably rectangular in shape with its long axis aligned with the long axis of the device and syringe so that the desired length of the syringe is exposed for viewing.

The guide slot 227 maintains alignment of three different components: a guide 233 that grasps the cover 228; a catch latch release 231; and a needle guard extension 241. The guide slot 227 ensures smooth activation of the device by maintaining alignment and vertical travel of the upper housing 202 and needle guard 208, as well as reliable latching and unlatching of the catch latch 231. Outwardly extending housing latches 229 secure the middle housing 201 to the lower housing 202 by engaging recesses, not shown, in the inner surface 243 of the middle housing 201. In a non-reusable embodiment of the device, the latch 229 and the recess are shaped such that the middle housing and the lower housing cannot be separated. For reusable embodiments, the grooves and latches are configured to enable the middle and lower housings to be pulled apart.

Referring to fig. 12, the needle guard 208 includes a needle guard slot 209 formed on one side by a grip latch release 231 and on the other side by a needle guard extension 241. Catch latch release 231 includes a ramped surface 240. Referring to fig. 14 and 15, ramped surface 240 of catch latch release 231 faces outward and engages inwardly facing ramped surface 244 of catch latch 224 as catch latch 231 travels upward, thereby deflecting catch latch 224 outward, thereby eliminating obstruction to downward movement of

guides

233 and 205.

The needle guard slot 209 allows the window 204 to be used to view the syringe 218 and the plunger 212 as the plunger 212 acts on the syringe 218 at the end of the downward stroke of the plunger. In addition, the needle guard return 214 is located within and at the bottom of the space formed by the capture latch release 231 and the needle guard extension 241.

One aspect of the device 200 is the manner in which the syringe 218 is suspended inside the device. Referring to fig. 12, 13A, 13B, 17A, and 17B, the syringe 218 is held between a needle shield 213 and a damper 221, each of which is a flexible member to protect the syringe 218 if the device 200 is dropped or otherwise mishandled. When the device is assembled, the syringe 218 is loosely held within the cavity 246 of the lower housing 202 by the retainer clip 235. Depending on the volume of medicament within the syringe 218, there may be some travel of the upper housing 205 before the damper 221 contacts the plunger 212 when the device is used, and during this initial downward travel, the damper 221 acts as an air piston to compress the air formed in the gap between the end of the plunger rod 215 and the plunger 212, which provides a rate-dependent resistance to movement for the initial downward movement of the grip. When the damper 221 moves rapidly, air cannot escape quickly enough to reduce the build-up of air pressure. The damper 221 may optionally include through holes, not shown therein, to allow air to leak through the damper 221. Alternatively, friction-based resistance from the damper may be used without pressure buildup, dampers in which there is no leakage and no rate dependence are used, or combinations thereof. Upon contact of damper 221 with plunger 212, damper 221 collapses inwardly toward plunger rod 215, thereby reducing friction between damper 221 and the inner surface of cavity 246.

Referring to fig. 10A-11C, when the user desires to use the device 200, the user removes the cap 203 from the lower housing 202, which action simultaneously removes the needle shield 213 and exposes the needle guard 208. The user grasps the device 200 by the upper housing 205, places the palm of the hand over the grip cap 228, and presses down on the grip cap 228 while holding the device 200 against the desired injection site on the body, which action slides the needle guard 208 upward, exposing the needle 210. Continued application of pressure to the gripping cap 228 causes the needle 210 to penetrate the user's skin and subcutaneous tissue, stopping when the lower housing base 206 contacts the skin surface or when the edge 245 of the needle guard 208 reaches the end of its travel within the lower housing 202.

Referring to fig. 15, when the needle guard 208 reaches its end of upward travel within the lower housing 202, the ramped surface 240 of the catch latch release 231 contacts an oppositely facing and complementarily ramped surface 244 of the catch latch 224 of the intermediate housing 201, deflecting the catch latch 224 toward the inner wall 243 of the intermediate housing 201. This action causes the stop surface 245 of the catch latch 224 to not interfere with the downward travel of the guide 233 of the catch cover 228, thereby releasing the guide 233 and allowing the upper housing 205 to move downward and over the intermediate housing 201.

As the upper housing 205 moves downward, the medicament within the syringe 218 is delivered through the needle 210 as the plunger rod 215 and the damper 221 grasping the cap 228 push the syringe plunger 212 downward. At the end of drug delivery, the body 207 is substantially completely covered by the upper housing 205, and the bottom edge 211 of the upper housing 205 has mated with the complementarily shaped travel ridge 216 of the lower housing 202. Also, plunger rod 215, damper 221 and plunger 212 are clearly visible within window 204. All of these features provide visual confirmation to the user that the medication has been delivered, and the hard stop of the bottom edge 211 against the travel ridge 216 provides tactile confirmation to the user.

In addition, the snap mechanism is activated at the end of drug delivery to provide audible feedback. Referring to fig. 14, when the ramps 247 of the snap latches 220 contact and slide over the top of the middle housing 201, the snap latches deflect outward. When the ramp 247 is moved down far enough, the ramp 247 aligns with the snap latch capture slot 236 and the ramp 247 slides into the capture slot 236, which extends through the wall at the proximal portion of the middle housing 201 and snaps against the outer surface of the body 207 of the middle housing 201, creating a clicking sound. In a non-reusable version of the device, the snap latch 220 is permanently captured by the capture slot 236 and cannot be reset. In a preferred embodiment, two snap latches 220 are positioned 180 degrees opposite each other in order to provide smooth activation of the device and enhance the snap and latch function.

When the user removes the device 200 from the skin, the needle guard return 214, shown in fig. 12 as a spring, is compressed by pressing the device 200 against the user's skin, stretching so that the needle guard 208 extends down over the needle 210, protecting the user from accidental sticks. In addition to the spring, the needle guard return can be a compressed gas actuator, a hydraulic drive, a wax actuator, an electrochemical actuator, a shape memory alloy, and the like, and combinations thereof. When needle guard 208 is fully extended, needle guard retainer 232 engages a stop 248 on lower housing 202, as shown in fig. 13A, thereby preventing needle guard 208 from separating from lower housing 202. In fig. 16, a needle guard latch 237 is shown movably attached at its distal end to an inner surface 243 of the intermediate housing 201. As needle guard 208 travels upward, needle guard latches 237 deflect outward upon contact with the outer surface of guide 233 or needle guard extension 241. As needle guard 208 travels downward and extends to cover needle 210, needle guard latch 237 slides over the top of needle guard extension 241, preventing needle guard 208 from retracting again.

Prior to use, extension guides 233 of grip cap 228 retain needle guard latches 237 in an outwardly deflected position, allowing needle guard 208 to retract for insertion of needle 210. Two needle guard holders 232 and needle guard latches 237 are preferably used and are positioned 180 degrees apart about the central axis of device 200. If the device 200 is removed from the skin before drug delivery is complete, the needle guard 208 will extend to cover the needle 210 and lock to prevent reuse of the device. In an alternative reusable embodiment, the needle guard 208 is extended but not locked into place with the device 200 removed from the skin prior to complete drug delivery.

Fig. 19 is a depiction of an alternative reusable embodiment of the device 200, wherein the upper housing 205 and the middle housing 201 are separable from the lower housing 202. In this embodiment, the user separates the middle and lower housings, inserts the syringe 218 into the lower housing, and then reattaches the middle and upper housings.

Another alternative embodiment of the device 200 is depicted in fig. 20, in which an auxiliary driver 219 is included. The secondary driver 219 may find its greatest utility in delivering viscous medicaments. The auxiliary drive 219 exerts a force between the upper housing 205 and the middle housing 201, thereby exerting a downward force on the upper housing sleeve 120. This reduces the amount of downward force that a user must apply to the gripping cap 228 in order to inject the medicament. The secondary drive 219 may be a spring, compression actuator, hydraulic drive, wax actuator, electrochemical actuator, shape memory alloy, or the like, or combinations thereof. Alternatively, the auxiliary drive may provide sufficient force to inject the medicament without requiring the user to input additional force, thereby providing an injection device in which the needle is manually inserted and the medicament is automatically injected in a manner similar to a conventional auto-injector.

An alternative embodiment of the lower housing 202 of the device 200 is depicted in fig. 21A-21C, which includes a repositionable snap mechanism for the reusable device. In this embodiment, guide slot 227 engages guide 225 of catch 222. Snap fitting 222 is biased by needle guard return 214. To set the catch 222, the user presses down on one of the catch guides 225 until the catch latch 226 extends past the catch 222, holding it down. As the grip cap 228 moves downward, at the end of travel, the guide 233 contacts a sloped surface on the snapper latch 226, deflecting it inward and releasing the snapper 222 to travel upward under the force of the needle guard return 214. A click sound is generated when the catch surface 223 of the catch 222 contacts the lower housing 202, signaling that the medicament has been fully delivered. As the needle guard 208 retracts during the drug injection, the compression of the needle guard return 214 increases, thereby increasing the force applied to the snap device and the volume of the click sound. Alternatively, the snap mechanism may be automatically reset when the user attaches the upper housing to the lower housing when a new syringe is loaded into the device.

Fig. 22A-30F depict another embodiment of a drug delivery device. As shown in fig. 22A-22E and 23, a delivery device 300 configured to deliver a drug defines a central axis a, a proximal end P, and a distal end D spaced from the proximal end D along the central axis a. As shown in fig. 22A and 22B, the apparatus 300 may include a lower housing 304, an upper housing 308, and an intermediate housing 312 coupled between the lower housing 304 and the upper housing 308. The device 300 may further include a needle guard 316 supported by the lower housing 304 and a cap 320 removably coupled to the lower housing 304 such that the needle guard 316 is exposed when the cap 320 is removed. The needle guard 316 is movable relative to the lower housing 304 in a first direction X1 from a first position in which the needle 332 of the device 300 is protected (e.g., as shown in fig. 22C) to a second position in which the needle 332 is exposed (e.g., as shown in fig. 22D). When device 300 is pressed against a tissue surface, needle guard 316 is configured to move from a first position to a second position, thereby allowing needle 332 of device 300 to be inserted into tissue. As shown in fig. 22C-22E and 23, the needle guard 316 includes a needle guard return 317, shown as a spring 318, that is configured to move the needle guard 316 in a second direction X2 opposite the first direction X1 from the second position toward the final position and over the needle 332 as the needle 332 is removed from the tissue (e.g., as shown in fig. 22E).

With continued reference to fig. 22A, 22B, and 23, the upper housing 308 is supported relative to the lower housing 304 and is configured to receive a manual force and move in the second direction X2 relative to the lower housing 304 from a pre-use position to a dispensing position in response to the manual force. As shown in fig. 22A and 22B, the middle housing 312 includes a body 315 that is exposed between the upper housing 308 and the lower housing 304 when the upper housing 308 is in the pre-use position and is substantially completely covered by the upper housing 308 when the upper housing 308 is in the dispensing position. Thus, the upper housing 308 is configured to move along the middle housing body 315 as the upper housing 308 moves toward the dispensing position.

As shown in fig. 22B, the upper housing 308 can define a first or bottom mating edge or surface 311, and the lower housing 304 can define a second or upper mating edge or surface 313 that mates with the bottom edge 311 of the upper housing 308 when the upper housing is in the dispensing position. The

edges

311 and 313 may be sinusoidal, as shown, and may provide a visual indication that the upper housing 308 has been moved to the dispensing position. It should be understood that

edges

311 and 313 can have any configuration as desired. For example, edges 311 and 313 may be flat as desired.

With continued reference to fig. 22C-22E and 23, the delivery device 300 further includes a syringe 324 supported by the lower housing 304 and a plunger rod 328 carried by the upper housing 308 and movable with the upper housing 308 to advance relative to the syringe 324 as the upper housing 308 is moved in the second direction X2. The syringe 324 is configured to hold a medicament and carries a needle 332 configured to be inserted into tissue. Advancement of the plunger rod 328 relative to the syringe 324 causes the syringe 324 to deliver the medicament out of the needle 332 and into the tissue. As shown in fig. 22A and 22B, the delivery device 300 also includes at least one window 336, such as a pair of windows 336, that provide an opening into the lower housing 304 for viewing the contents of the syringe 324. As shown in fig. 22A, 22B, and 23, lower housing 304 and middle housing 312 together define a window 336 such that window 336 is located near the distal end of device 300. Thus, the window 336 is positioned such that the bottom of the syringe 324 is visible to the user, allowing the user to verify that the plunger rod 328 has reached the end of its travel to the bottom of the syringe 324. The window 336 may be rectangular along the illustrated first direction X1, but it should be understood that the window 336 may have any size and shape as desired.

As shown in fig. 23, the cap 320 is removably attached to the lower housing 304 such that removal of the cap 320 exposes the needle guard 316 and removes the needle shield 338 from the syringe 324, thereby exposing the needle 332 within the needle guard 316. As shown in FIG. 23, the cap 320 includes a cap body 340 and a needle shield clamp 344 attached to the cap body 340. The cap body 340 defines a cavity 348 that receives the needle guard 316 when the cap 320 is attached to the lower housing 304, and a cap retaining ring 352 that grips the lower housing 304 to removably couple the cap 320 to the lower housing 304. As shown in fig. 23, the cap retaining ring 352 defines a pair of detents 356 configured to receive the pair of tabs 350 defined by the lower housing 304 to removably couple the cap 320 to the lower housing 304. To remove the cap 320, the lower housing 304 may define a pair of tabs on either side of the protrusion 350 that allow the cap to be unscrewed. For example, the tabs may engage cam surfaces on the cover such that when the cover is twisted, the tabs push the cover away from the lower housing 304. However, it should be understood that cover retaining ring 352 may include any feature that removably couples cover 320 to lower housing 304 as desired.

With continued reference to fig. 22C and 23, the needle shield clip 344 can be coupled to the cap body 340 within the cavity 348. The needle shield clamp 344 is configured to grip the needle shield 338 when the cap 320 is coupled to the lower housing 304. The needle shield 338 is attached to the syringe 324 such that the needle shield 338 encloses the needle 332. When the cap 320 is removed from the lower housing 304, the needle shield clamp 344 grasps the needle shield 338 such that the needle shield 338 is removed from the lower housing 304 with the cap 320. When the cap 320 is removed, the device 300 may be positioned against a tissue surface and subsequently activated in order to inject the drug into the tissue.

Referring now to fig. 23 and 24A-24C, the upper housing 308 can include a skirt 360, a housing body 364 mounted to the skirt 360, and a grip cap 368 mounted to the housing body 364. As shown in fig. 24A and 24B, the upper housing 308, and in particular the housing body 364, includes a capture cap mounting member 372 and a pair of guides 376 extending distally from the capture cap mounting member 372 in the second direction X2. As shown in fig. 23, the grip cover 368 may be coupled to the grip cover mounting member 372, and the guide 376 may extend through the skirt 360 when the housing body 364 is mounted to the skirt 360.

The capture cover mounting member 372 may be dome-shaped so as to define a substantially convex proximal surface 374 and a distal surface 375 opposite the proximal surface 374. The grip cover 368 may also be dome-shaped and may be mounted to the grip cover mounting member 372 such that the grip cover 368 overlies the proximal surface 374. As shown in fig. 24A, mounting member 372 can include a plurality of securing members 380 extending from distal surface 375. The securing members 380 may each define a hole 381 configured to receive a corresponding securing member, such as a locking pin 382, defined by the skirt 360, thereby coupling the housing body 364 to the skirt 360. However, it should be understood that the securing

members

380 and 382 may have any configuration as desired. For example, the securing member 380 of the mounting member 372 may define a locking pin and the securing member 382 of the skirt 360 may define a hole. It should also be appreciated that the grip cover 368 and the housing body 364 may be integrally formed as desired, and that the grip cover 368 and the mounting member 372 may have any shape as desired.

As shown in fig. 24A, upper housing 308 can further include at least one locking latch 390, such as a pair of locking latches 390 extending from distal surface 375 of mounting member 372 and toward lower housing 304. The locking latch 390 is configured to lock the upper housing 308 in the dispensing position after the upper housing 308 has been moved from the pre-use position to the dispensing position in order to prevent reuse of the device 300. The locking latches 390 can be resiliently flexible and can each include a flexure member 392 extending from the mounting member 372 and a protrusion 394 extending from a distal end of the flexure member 392 toward the central axis a. As shown in fig. 22C-22E, locking latches 390 face each other such that projections 394 extend toward each other in a direction transverse to second direction X2. As shown in fig. 22C-22E, as the upper housing 308 moves along the middle housing 312, the locking latches 390 will engage the lower housing 304 and flex away from each other. When the upper housing 308 reaches the dispensing position, the locking latches 390 will move back toward each other such that the protrusions 394 engage corresponding latch members of the lower housing 304, thereby locking the upper housing 308 in the dispensing position. When locking latch 390 engages the corresponding latch member, an audible click may be generated, indicating to the user that the injection is complete. However, it should be understood that the locking latches 390 may have any configuration, and the upper housing 308 may have any number of locking latches, as desired. For example, the upper housing 308 may include a single locking latch as desired.

As shown in fig. 22C, 23 and 24A-24B, each guide 376 of the housing body 364 extends through the skirt 360 and into the intermediate housing 312. Each guide 376 may include a guide body 377 that is elongated in the second direction X2 and extends from the mounting member 372 such that the guides 376 face each other in a direction transverse to the second direction X2. The guide 376 is configured to temporarily interfere with the lower housing 304 to maintain the upper housing 308 in the pre-use position until the needle guard 316 has moved to the second position and the needle 332 is inserted into tissue. In this way, accidental dispensing of the medicament can be avoided.

As shown in fig. 24A, each guide 376 may define an abutment surface 398 facing at least partially toward the lower housing 304 and a channel 400 extending through the guide body 377 from the distal end of the guide body 377 and toward the proximal end of the guide body 377. The abutment surface 398 is configured to engage the lower housing 304 when the upper housing 308 is in the pre-use position, thereby maintaining the upper housing 308 in the pre-use position until the needle guard 316 is moved to the second position. The abutment surface 398 may be disposed proximate to the distal end of the guide body 377. The abutment surface 398 may define a plane perpendicular to the first direction X1 and may include an inclined portion defining a slope leading to the respective channel 400. The channel 400 extends completely through the guide body 377 in a direction transverse to the second direction X2 and extends along a substantial portion of the guide body 377 in the second direction X2. The channel 400 is configured to act as a release or guide for the lower housing 304 when the interference between the upper housing 308 and the lower housing 304 is removed and the upper housing 308 is moved toward the dispensing position. That is, when the interference is removed and the upper housing 308 moves toward the dispensing position, the portion of the lower housing 304 that interferes with the upper housing 308 will move within the channel 400. However, it should be understood that the abutment surface 398 and the channel 400 may have any configuration as desired. For example, the abutment surface 398 may be angled, and the channel 400 may extend into, but not completely through, the guide body 377 as desired.

As shown in fig. 24C, the skirt 360 includes a skirt body 404 having an inner surface 408 defining a channel 412 extending completely through the skirt body 404 in the second direction X2. The upper housing 308 is coupled to the middle housing 312 such that the middle housing 312 is received within the channel 412 and the middle housing 312 is configured to move through the channel 412 as the upper housing 308 moves toward the dispensing position. As shown in fig. 24C, skirt 360 includes at least one friction member 416, such as four friction members 416 extending from inner surface 408 and toward central axis a. The friction members 416 are configured to interfere with corresponding friction members defined by the intermediate housing 312 to generate a frictional force as the upper housing 308 is moved from the pre-use position toward the dispensing position. When a manual force is applied to the upper housing 308, the frictional force increases the resistance, thereby preventing the upper housing 308 from being abruptly moved in the second direction X2. For example, in the event that the syringe 324 is only partially filled with medicament and the plunger rod 328 is not in contact with the plunger within the syringe 324, friction forces may prevent the upper housing 308 from moving abruptly. When the needle guard 316 is in the second position, the frictional force generated by the friction member should be greater than or equal to the force of the compressed needle guard spring 318, thereby preventing the needle guard spring 318 from lifting the lower housing 304 and pulling the needle 332 out of the tissue before the plunger rod 328 contacts the plunger. However, it should be understood that the frictional force may be any desired force. For example, skirt 360 and intermediate housing 312 may be free of friction members such that the friction force is substantially zero. It should also be appreciated that skirt 360 may define any number of friction members 416 as desired.

With continued reference to fig. 24C, each friction member 416 may define a rail 420 that protrudes from the inner surface 408. As shown in fig. 24C, each rail 420 can taper as the rail 420 extends from the distal end of the skirt 360 toward the proximal end of the skirt 360. Thus, the frictional force when the upper housing 308 begins to move from the pre-use position may be greater than the frictional force when the upper housing 308 approaches the dispensing position. However, it should be understood that the rail 420 may have any configuration as desired. For example, the guide rail 420 may not be tapered such that the frictional force between the upper housing 308 and the intermediate housing 312 is constant along the entire movement of the upper housing 308.

Referring now to fig. 25A and 25B, the intermediate housing body 315 includes a side wall 464 and at least one friction member 468, such as four friction members 468 carried by the side wall 464. Each friction member 468 is configured to interfere with a respective friction member of the friction members 416 of the upper housing 308. As shown in fig. 25A, each friction member 468 can be configured to be coupled to a cantilevered portion 472 of the side wall 464 at a hinge 474, such that each cantilevered portion 472 is configured to flex relative to a central axis (e.g., central axis a) of the middle housing 312 as the upper housing 308 is moved toward the dispensing position. As shown in fig. 25A, the side wall 464 is substantially cylindrical and includes four slots 478, each defining a respective cantilevered portion 472. Each slot 478 extends from the proximal end of the intermediate housing body 315 and terminates at a respective hinge 474. In the illustrated embodiment, the hinges 474 are oriented such that the cantilevered portions 472 flex about respective axes parallel to the central axis a. As shown in fig. 25A, the cantilevered portion 472 defines a first pair of cantilevered portions and a second pair of cantilevered portions each having a first cantilevered portion 472a and a second cantilevered portion 472 b. The first and second

cantilevered portions

472a, 472b of each pair extend away from each other. That is, the first cantilevered portion 472a of the first and second pairs extends clockwise about the side wall 464 and the second cantilevered portion 472b of the first and second pairs extends counterclockwise about the side wall 464. Accordingly, each cantilevered portion 472 may be curved so as to define a radius relative to the central axis a. However, it should be understood that cantilevered portion 472 can have any configuration and hinge 474 can have any configuration as desired. It should also be appreciated that the friction member 468 is not limited to the cantilevered portion 472 and may include any configuration as desired. For example, the friction member 468 may be an elastomeric pad on the outer surface of the side wall 464.

With continued reference to fig. 25A-25B, each cantilevered portion 472 can be located near a proximal end of the middle housing 312. Each cantilevered portion 472 may include an outer elastomeric portion 480 configured to contact a respective rail 420. Elastomeric portion 480 may be used to increase the coefficient of friction of the surface of cantilevered portion 472 in contact with rail 420, thereby changing the resistance. Initially, as the upper housing 308 begins to move from the pre-use position, the thicker portion of the rail 420 comes into contact with the elastomeric portion 480, causing the cantilevered portion 472 to flex inwardly toward the central axis a and apply a biasing force against the rail 420, as shown in fig. 25C. The interference between the guide rails 420 and the cantilevered portion 472 creates a frictional force that resists movement of the upper housing 308 toward the dispensing position. As the upper housing 308 moves further toward the dispensing position, the guide rails 420 taper such that the biasing force against the guide rails 420 decreases and the resistance to downward movement of the upper housing 308 decreases.

Referring now to fig. 26A and 26B, the lower housing 304 includes a base 490 and a lower housing body 494 extending from the base 490 in the first direction X1. The base 490 includes a skin-facing surface 498 that is configured to face (although it may not necessarily contact) the individual's skin when the needle 332 is inserted into tissue. The base 490 also defines a cavity 502 that extends into the skin-facing surface 498 and is configured to receive the needle guard 316 when the needle guard 316 is moved to the second position. The lower housing body 494 defines a pair of first channels 506a extending along the lower housing body 494 in the first direction X1 and a pair of second channels 506b extending along the lower housing body 494 in the first direction X1 adjacent to the first channels 506 a. Each channel 506a is sized to receive a respective guide 376 of the upper housing 308 such that the guide 376 advances in the second direction X2 within the first channel 506a as the upper housing 308 moves toward the dispensing position. The second channel 506b is configured to receive a portion of the needle guard 316 such that the portion of the needle guard 316 is disposed between the lower housing body 494 and the guide 376 and is movable within the channel 506b in the first direction X1 and the second direction X2.

As shown in fig. 26A and 26B, the lower housing 304 further includes at least one housing latch 510, such as a pair of housing latches 510, each of which includes a protrusion 514 to releasably interfere with the upper housing 308 when the upper housing 308 is in the pre-use position so as to prevent the upper housing 308 from moving toward the dispensing position. The protrusion 514 may be positioned substantially at the terminal end of each respective housing latch 514. Further, each protrusion 514 may define a radially extending protrusion that extends substantially perpendicular to the first and second directions X1 and X2, although other orientations of protrusions 514 are contemplated. As shown in fig. 26B, each housing latch 510 includes a leg 512 extending generally upwardly from a corresponding portion of the lower housing body 494 and a rib 516 extending laterally from a portion of a laterally facing surface 518 of the leg 512 of the housing latch 510. The aforementioned protrusion 514 extends from the proximal end of the leg 512 away from the central axis a and into the channel 400 defined by the guide 376. In the embodiment shown in fig. 26A-26B, each leg 512 can include a first portion 520 extending from the lower housing body 494 generally parallel to the central axis a, and a second portion 522 extending from an end of the first portion in a lateral direction at an angle relative to the first portion 520 toward the protrusion 514.

The housing latch 510 is resiliently flexible such that the housing latch 510 is configured to flex or otherwise move out of interference with the upper housing 308 as the upper housing 308 moves from the pre-use position and toward the dispensing position. Specifically, housing latch 510 may include a cantilevered body configured to flex about a base of first portion 520. The protrusion 514 engages the abutment surface 398 of the guide 376 to prevent the upper housing 308 from moving toward the dispensing position. When the needle guard 316 has moved to the second position and the housing latch 510 is free to flex, movement of the upper housing 308 toward the dispensing position causes the projection to move into and along the channel 400 of the guide rail 376 and thereby disengage from interference with the upper housing 308. It should be appreciated that housing latch 510 can have any configuration as desired and can extend from any portion of lower housing body 494. For example, each leg 512 can extend downward from a corresponding portion of the lower housing body 494.

With continued reference to fig. 26A and 26B, the lower housing 304 further includes at least one latch member 530, such as a pair of latch members 530 configured to mate with the locking latches 390 of the upper housing 308 when the upper housing 308 is in the dispensing position. As shown in fig. 26A, each latch member 530 can define a ramp 532 that projects radially outward to a greater extent as it extends in a distal direction from the lower housing body 494, and a shelf 534 at a distal end of the ramp 532. The shelf 534 defines a surface facing the distal end of the device. As the upper housing 308 moves toward the dispensing position, the protrusions 394 of the locking latches 390 will ride along the ramps 532 and flex increasingly away from each other due to the engagement between the housing latches 390 and the ramps 532. When the upper housing 308 reaches the dispensing position, the locking latch 390 will reach the distal end of the latch member 530 and thus snap over the latch member 530 and return substantially to its original position such that the projection 394 engages the shelf 534, thereby locking the upper housing 308 in the dispensing position. In particular, the protrusion 394 abuts a surface of the shelf 534 to prevent the upper housing 308 from moving rearward toward the pre-use position. However, it should be understood that the latch member 530 may have any configuration as desired. For example, the latch member 530 can be a slot defined in the lower housing body 494 that receives the protrusion 394.

As the locking latch 390 travels along the ramp 532, contact between the protrusion 394 of the locking latch 390 and the ramp 532 may create a frictional force that increases the resistance to a downward manual force applied to the upper housing 308 to move the upper housing 308 to the dispensing position. In this manner, locking latch 390 and latch member 530 may also be considered friction members. That is, the guide rail 420 and the cantilevered portion 472 can be considered a primary friction member, and the locking latch 390 and the latch member 530 can be considered a secondary friction member.

Referring now to fig. 23 and 27A-27C, the syringe 324 may include a bottom shoulder 540 proximate the needle 332 and an upper edge 544 spaced from the bottom shoulder 540 along the first direction X1. As shown in fig. 27A-27C, the device 300 can further include a syringe retainer 548 configured to receive the syringe 324 and support the syringe 324 at the bottom shoulder 540. The syringe retainer 548 may include a main body 552 and a pair of resiliently flexible legs 556 extending from the main body in the second direction X2. The resiliently flexible legs 556 are spaced apart from each other in a direction perpendicular to the second direction X2 such that a gap 560 is defined between the resiliently flexible legs 556. Each resiliently flexible leg 556 includes a tab 564 that extends toward the other leg 556 such that when the syringe 324 is moved through the gap 560 in the second direction X2 and toward the seated position, the resiliently flexible legs 556 move away from each other and when the syringe 324 is in the seated position, the resiliently flexible legs 556 move back toward each other such that the tabs 564 engage the bottom shoulder 540 of the syringe 324. Once the syringe retainer and retainer combination is inserted into the lower housing 304, the flexible legs 556 remain in place and cannot flex outwardly any further, thereby supporting the syringe 324. In the illustrated embodiment, the tab 564 is disposed at a distal end of the leg 556. However, it should be understood that the tab 564 may be disposed anywhere along the leg 556 as desired.

With continued reference to fig. 27A, the retainer 548 further includes a hole 572 extending through the body 552 and into the gap 560, and at least one catch 576 carried by the body 552 within the hole 572. The at least one grip 576 is configured to abut the syringe 324 to prevent the syringe 324 from moving through the gap 560 in the first direction X1 after the syringe 324 is in the seated position. Grip 576 may be an elastomeric portion, a rib, or any other structure capable of preventing syringe 324 from being withdrawn from the gap.

As shown in fig. 27A and 22C, the retainer 548 further includes at least one locking tab 580, such as a pair of locking tabs 580, extending outwardly from the body 552 away from the central axis a. The locking tabs 580 are configured to abut the lower housing 304, thereby locking the syringe retainer 548 within the lower housing 304. The locking tabs 580 may be flexible such that when the retainer 548 is seated in the lower housing 304, the locking tabs 580 flex toward the central axis a and then move back to their original positions when the retainer 548 is fully seated within the lower housing 304 such that the locking tabs 580 engage corresponding portions of the lower housing 304, thereby locking the retainer 548 and the syringe 324 in the lower housing 304. However, it should be understood that the retainer 548 can have other configurations as desired. For example, locking tabs 580 may extend from the leg 556 as desired.

Referring now to fig. 23, 22C-22E, and 28A-D, when the needle guard 316 is pressed against the skin surface, the needle guard 316 may be moved relative to the lower housing 304 in the first direction X1 from the first position to the second position, and then when the device 300 is removed from the skin surface, may be moved in the second direction X2 (e.g., by the force of the needle guard return 317) from the second position to the final position. As shown in fig. 28A, the needle guard 316 includes a housing 600 and a pair of extensions 604 extending from the housing 600 in a first direction X1. The housing 600 houses the needle 332 when the needle guard 316 is in the first and final positions. When the needle guard 316 is moved to the second position, the needle 332 protrudes from the housing 600 and is inserted into tissue.

As shown in fig. 23 and 28A-D, the extensions 604 oppose each other to define a gap 618 therebetween and are each configured to move within the respective second channel 506b of the lower housing 304 such that the extensions 604 are each disposed between the lower housing body 494 and the respective guide 376 of the upper housing 308 (see fig. 28C, 28D). As shown in fig. 28A, 28B, each extension 604 defines a stop 612 configured to contact or otherwise abut a respective housing latch 510, such as a protrusion 514 of the housing latch 510, when the needle guard 316 is in the first position, so as to maintain the housing latch 510 in interference with the upper housing 308. As needle guard 316 moves toward the second position, housing latch 510 moves out of contact with stop 612. The housing latch 510 may then be moved out of interference with the upper housing 308 such that the upper housing 308 can be moved toward the dispensing position. Thus, the upper housing 308 may remain in the pre-use position until the needle guard 316 has moved to the second position.

With continued reference to fig. 28A, 28B, the needle guard 316 also defines an opening 616 in each extension 604. Each extension 604 also includes a needle guard latch 620 that extends upward from the extension 604 and into the opening 616 and a protrusion 606 that extends laterally from the extension 604 into the opening 616. Each projection 606 includes a cam 607 that projects radially inward from the projection 606 so as to extend into the gap 618. Each needle guard latch 620 is resiliently flexible and its positioning with the portion of the opening 616 on each lateral side of the latch 620 allows the latch 620 to flex laterally in multiple directions. The latch 620 also defines a groove 624 at its proximal end and a hinge 628 at its distal end. The needle guard latch 620 is configured to flex laterally about its hinge 628 toward the corresponding protrusion 606 as the needle guard 316 moves from the second position to the final position and when the upper housing 308 is in the dispensing position. As shown in fig. 28, each needle guard latch 620 defines a sidewall 632 extending from the hinge 628 to the channel 624. At least a portion of each sidewall 632 proximate to the trench 624 is angled relative to the first or second direction. As the upper housing 308 moves toward the dispensing position, the protrusion 514 of the housing latch 510 may travel along the angled side wall portion 632 to laterally deflect the needle guard latch 620 as the needle guard 316 moves from the second position to the final position. When device 300 is then removed from the tissue and needle guard 316 is moved to the final position, needle guard latches 620 will flex back toward their initial position such that grooves 624 receive protrusions 514 of housing latches 510, thereby locking needle guard 316 in the final position.

As shown in fig. 29A-29F, the housing latch 510 can be configured to selectively retain both the upper housing 308 in the pre-use position and subsequently the needle guard 316 in the final position. As shown in fig. 29A, when the upper housing 308 is in the pre-use position and the needle guard 316 is in the first position, the protrusion 514 of the housing latch 510 abuts the corresponding abutment surface 398 of the guide 376 of the upper housing 308 to prevent the upper housing 308 from moving toward the dispensing position. As shown in fig. 29A, the stopper 612 of the needle guard 316 abuts the protrusion 514 and maintains the interference of the protrusion 514 with the abutment surface 398. In the pre-use position, the laterally facing surface 518 of the housing latch 510 is preferably laterally spaced from the corresponding cam 607 on the protrusion 606 of the extension 604 of the needle guard 316. As shown in fig. 29A and 29B, due to the angling of the second portions 522 of the legs 512 of the housing latches 510, when the needle guard 316 is moved from the pre-use position to the second position, the cams 607 move proximally relative to the lower housing 304 and the laterally facing surfaces 518 of the housing latches 510 abut and interact with opposing laterally facing surfaces of the respective cams 607. The force exerted by cam 607 on laterally facing surface 518 of housing latch 510 causes housing latch 510 to flex laterally away from corresponding protrusion 606 of needle guard 316 such that protrusion 514 of housing latch 510 is aligned with channel 400 of guide 376. The ribs 516 on the legs 512 are preferably located radially inward of the respective cam 607 when the needle guard 316 is moved to the second position. In addition, the protrusion 514 moves away from the stop 612 so that the housing latch 510 can move out of interference with the abutment surface 398 of the upper housing 308 and the upper housing 308 can move toward the dispensing position.

As shown in fig. 29C and 29D, when the upper housing 308 is moved toward the dispensing position (and when the needle guard 316 is in the second position), the protrusion 514 moves into and along the channel 400 of the guide 376 to inject the medicament through the needle 332 as the upper housing 308 receives a force from the user in the second direction X2. As shown in fig. 29D, the protrusions 514 travel along the angled side wall portions 632 of the needle guard latches 620 and cause the needle guard latches 620 to flex away from the protrusions 514 so that the protrusions 514 may continue their travel along the channel 400. As shown in fig. 29E and 29F, after the injection has been completed and the upper housing 308 is locked with the lower housing 304 in the dispensing position, the delivery device 300 can be removed from contact with the patient. As a result, the needle guard spring 318 moves the needle guard 316 from the second position toward the final position and the protrusion 514 travels along the side wall 632 until the needle guard latch 620 flexes back toward its original position. This allows the groove 624 to receive the protrusion 514, thereby locking the needle guard 316 in a final position, e.g., preventing the needle guard 316 from moving proximally. In this manner, the housing latch 510 may be configured to retain the upper housing 308 in the pre-use position (pre-injection) and lock the needle guard 316 in the final position (post-injection).

In operation and referring to fig. 30A-30F, the delivery device 300 can be configured to deliver a drug. Prior to use (fig. 30A), the upper housing 308 may be locked in a pre-use position by the housing latch 510, and the cap 320 may be coupled to the lower housing 304 so as to shield the needle guard 316 and needle 332. When the device 300 is ready for use, the cap 320 can be removed from the lower housing 304 such that the cap 320 removes the needle shield 338 from the needle 332, as shown in fig. 29A, 30B.

As shown in fig. 30C, the device 300 can be positioned against a skin surface and a manual force can be applied to the upper housing 308 in an insertion direction (e.g., a second direction) such that when the needle guard 316 is pressed against the skin surface, the needle guard 316 moves to a second position and the needle 332 is inserted into tissue. When the needle guard 316 is moved to the second position (fig. 29B, 29C), the stop 612 is moved out of engagement with the housing latch 510 such that the upper housing 308 is no longer locked in the pre-use position. As shown in fig. 30D and 30E, the upper housing 308 may then be moved in the second direction and over the middle housing 312. When the upper housing 308 reaches the dispensing position (as shown in fig. 29D, 30E), substantially all of the intermediate housing 312 is covered by the upper housing 308 and the plunger is visible within the window 336, providing visual evidence that all of the medicament has been delivered to the tissue.

Further, when the upper housing 308 reaches the dispensing position, the locking latch 390 of the upper housing 308 engages the latch member 530 of the lower housing 304, thereby locking the upper housing 308 in the dispensing position to prevent reuse of the delivery device 300. When locking latch 390 snaps over latch member 530, an audible click is generated that indicates to the user that upper housing 308 has reached the dispensing position and is locked in the dispensing position. The upper housing 308 may be permanently locked in the dispensing position so that the device 300 is not reusable. However, it should be understood that the upper housing 308 may be temporarily locked so that the device 300 may be sterilized and reused.

As shown in fig. 29F, 30F, when the device 300 is removed from the skin surface in a direction opposite the insertion direction, the needle guard 316 moves in the second direction X2 to a final position. When in the final position, housing latch 510 interferes with needle guard latch 620, locking needle guard 316 in the final position. In this manner, the needle guard 316 may be permanently locked in a final position such that the device 30 is not reusable. However, it should be understood that the needle guard 316 may be temporarily locked such that the device 300 may be sterilized and reused.

As shown in fig. 30B and 30F, the needle guard 316 may be configured to move a first distance d1 from the first position to the second position in the first direction X1 and a second distance d2 from the second position to the final position in the second direction X2. The second distance d2 may be greater than the first distance d1, thereby indicating to the user that the needle guard 316 is actually in the final position and locked. The needle guard 316, and in particular the housing 600 of the needle guard 316, may include a visual indication 640, such as a colored band, at the proximal end of the housing 600 that is visible only when the needle guard 316 is in the final position. Visual indication 640 may be formed, for example, by forming overmold 641 (preferably made of a polymeric or elastomeric material) on a portion of housing 600 having a different color than housing 600. In this example, the exposed proximal portion of housing 600 would then form a ribbon 640 that contrasts with the color of overmold 641. To improve patient comfort, overmold 641 may further cover portions of housing 600 intended for patient contact where the material is preferably softer than that of housing 600, which may need to be more rigid to protect needle 332. However, it should be understood that the needle guard 316 may move any distance from the first position to the second position and any distance from the second position to the final position.

While the foregoing description and drawings represent exemplary embodiments, it will be understood that various additions, modifications, combinations and/or substitutions may be made therein without departing from the spirit and scope of the present invention as defined in the accompanying claims. In particular, it will be clear to those skilled in the art that the present invention may be embodied in other specific forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the spirit or essential characteristics thereof. Those skilled in the art will appreciate that the invention may be used with many modifications of structure, arrangement, proportions, materials, and components and otherwise, used in the practice of the invention, which are particularly adapted to specific environments and operative requirements without departing from the principles of the present invention. In addition, the features described herein may be used alone or in combination with other features. For example, features described in connection with one component may be used and/or interchanged with features described in another component. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, and not limited to the foregoing description.

It will be appreciated by persons skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. Some of the various modifications and alterations have been discussed above, and others will be apparent to those skilled in the art. This includes multi-dose designs where one or both of the upper and middle housings are raised to a partial height and a portion of the syringe is delivered when depressed by the user. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present disclosure as set forth in the appended claims.

Claims

1. A device configured to administer a medicament, the device comprising:

a lower housing configured to support a drug-retaining syringe having a needle, the lower housing including a housing latch including a leg extending proximally from a portion of the lower housing to a free tip and a protrusion extending radially from the leg, the leg being laterally resiliently flexible relative to an axial central axis of the device;

a needle guard supported by and in sliding engagement with the lower housing, the needle guard movable in a proximal direction relative to the lower housing from a first position in which a distal end of the needle guard is configured to conceal a distal tip of the needle to a second position in which the distal end of the needle guard is configured to expose the distal tip of the needle, the needle guard including an elongate extension having an opening that receives the radially extending protrusion of the housing latch therethrough, the needle guard further including a protrusion extending laterally into the opening, the laterally extending protrusion having a cam extending radially inward from the laterally extending protrusion; and

an upper housing having an abutment surface, the upper housing supported relative to the lower housing and configured to receive a distally directed manual force and move in a distal direction relative to the lower housing from a pre-use position to a dispensing position in response to the manual force;

wherein:

the radially extending projection of the housing latch releasably interferes with the abutment surface of the upper housing when the upper housing is in the pre-use position and the needle guard is in the first position, preventing movement of the upper housing relative to the lower housing toward the dispensing position, and,

proximal movement of the needle guard from the first position to the second position moves the cam of the needle guard into abutment with the leg of the housing latch, the cam resiliently deflecting the leg laterally to move the radially extending projection of the housing latch out of interference with the abutment surface of the upper housing to release the upper housing to move from the pre-use position to the dispensing position in response to the manual force.

2. The device of claim 1, wherein the opening defines a proximally located stop surface that releasably interferes with the radially extending protrusion of the housing latch to maintain the releasable interference of the radially extending protrusion of the housing latch with the abutment surface of the upper housing when the upper housing is in the pre-use position and the needle guard is in the first position.

3. The device of claim 2, wherein the proximal movement of the needle guard from the first position to the second position releases the radially extending protrusion of the housing latch from the stop surface of the needle guard.

4. The device of any one of the preceding claims, wherein the radially extending protrusion of the housing latch extends from the free end of the leg.

5. The device of any one of the preceding claims, wherein the leg includes a first portion extending from the portion of the lower housing in a direction generally parallel to the central axis and a second portion extending laterally from a proximal end of the first portion toward the free tip of the leg at an angle relative to the first portion such that the second portion is not parallel to the central axis.

6. The device of any one of the preceding claims, wherein the leg further comprises a laterally facing surface and a rib extending laterally from a portion of the laterally facing surface.

7. The device of claim 6, wherein the rib of the lower housing is positioned radially inward of the cam of the needle guard.

8. The device of claim 6, wherein the cam of the needle guard is laterally spaced from the laterally facing surface of the leg of the lower housing latch in the pre-use position of the upper housing and the first position of the needle guard.

9. The device of any of the preceding claims, wherein the needle shield further comprises a housing and the elongate extension is one of a pair of opposing elongate extensions extending proximally from the housing, the pair of opposing elongate extensions defining a gap therebetween.

10. The device of claim 9, wherein the leg of the housing latch is positioned within the gap and the cam extends radially inward into the gap.

11. The device of any one of the preceding claims, further comprising the drug-holding syringe having the needle.

12. The device of claim 11, further comprising a plunger rod carried by the upper housing and movable with the upper housing for advancement relative to the syringe when the upper housing is moved from a pre-use position to the dispensing position, wherein advancement of the plunger rod relative to the syringe causes the syringe to deliver the medicament out of the needle.

13. The device of any one of the preceding claims, wherein the needle guard is configured to move in the distal direction from the second position to a final position when the upper housing is in the dispensing position, wherein the needle guard covers the needle in the final position.

14. The device of claim 13, wherein the final position of the needle guard is distal to the first position of the needle guard.

15. The device of claim 13, wherein a visual indication on the needle guard is covered by the lower housing when the needle guard is in the first and second positions, and wherein the visual indication is spaced distally from the lower housing when the needle guard is in the final position.